Surgical Template and Delivery Device

ABSTRACT

The present disclosure provides devices and methods relating to surgical breast procedures. The devices can include a holder and backing to assist in positioning a biological material adjacent to a tissue expander or implant.

This application is a divisional application of U.S. patent applicationSer. No. 13/804,741 filed on Mar. 14, 2013, which claims priority under35 U.S.C. § 119 to U.S. Provisional Patent Application No. 61/709,692,filed on Oct. 4,2012. The entire contents of each of theabove-referenced applications are incorporated herein by reference.

The present disclosure relates generally to devices for positioning asample of biocompatible material during breast procedures, as well asmethods for treating tissue sites with the device.

Surgical breast procedures can use a tissue expander or a breast implantand a sample of biocompatible material, which can provide support tosurrounding tissue. Proper placement of the material can be difficult toachieve, but can be important to the outcome of a breast procedure.Accordingly, there is a need for devices to assist in the placement ofsuch biocompatible materials during surgical breast procedures.

According to various embodiments, a device for surgical breastprocedures is provided. The device can comprise a holding membercomprising a proximal edge and a distal edge and a first side and asecond side, wherein the proximal edge comprises a convex portioncurving away from the distal edge and the distal edge further comprisesa convex portion curving away from the proximal edge. The device canfurther comprise a backing member associated with the holding member andcomprising a first dimension and a second dimension, and at least onefastener configured to be connected to the holding member proximate tothe proximal edge and configured to hold a sample of biocompatiblematerial in apposition to the first side of the holding member.

According to certain embodiments a system for facilitating breastsurgery is provided. The system can comprise a sample of biocompatiblematerial. The system can further comprise a holding member comprising aproximal edge and a distal edge and a first side and a second side,wherein the proximal edge comprises a convex portion curving away fromthe distal edge, and the distal edge further comprises a convex portioncurving away from the proximal edge and at least one indentationpositioned along the distal edge. The system can also comprise a backingmember comprising a first dimension and a second dimension, and at leastone fastener configured to hold the sample of biocompatible material inapposition to the first side of the holding member.

According to certain embodiments, a method for preparing a site within abreast is provided. The method can comprise creating a tissue pocketwithin or posterior to a breast; and positioning within the tissuepocket a template comprising a sample of biocompatible materialcomprising a proximal edge and a distal edge, a holding membercomprising a proximal edge and a distal edge, and a backing member,wherein the proximal edge of the biocompatible material is detachablyconnected proximate to the proximal edge of the holding member and thebacking member is detachably connected proximate to the distal edge ofthe holding member. The method can further comprise fastening the distaledge of the biocompatible material to tissue within or surrounding thetissue pocket; and removing the holding member and the backing memberfrom the tissue pocket.

According to certain embodiments, a device is provided. The device cancomprise a holding member comprising a proximal edge and a distal edgeand a first side and a second side, wherein the proximal edge comprisesa convex portion curving away from the distal edge and the distal edgefurther comprises a convex portion curving away from the proximal edge,wherein the distal edge of the holding member comprises multipleindentations positioned along the distal edge. The device can furthercomprise at least one fastener configured to be connected to the holdingmember proximate to the proximal edge and configured to hold a sample ofbiocompatible material in apposition to the first side of the holdingmember.

According to certain embodiments, a system for treating tissue isprovided. The system can comprise a sample of biocompatible material anda holding member. The holding member can comprise a proximal edge and adistal edge and a first side and a second side, wherein the proximaledge comprises a convex portion curving away from the distal edge andthe distal edge further comprises a convex portion curving away from theproximal edge, wherein the distal edge of the holding member comprisesmultiple indentations positioned along the distal edge. The system canfurther comprise at least one fastener configured to be connected to theholding member proximate to the proximal edge and configured to hold asample of biocompatible material in apposition to the first side of theholding member.

According to certain embodiments, a method for performing breast surgeryis provided. The method can comprise creating a tissue pocket in abreast and inserting a holding member into the tissue pocket, whereinthe holding member includes a sample of biocompatible material attachedthereto. The method can further comprise contacting a portion of thebreast with a distal edge of the holding member and fastening the sampleof biocompatible material to tissue within the breast, wherein thesample of biocompatible material is attached to the holding memberduring fastening. The sample of biocompatible material can also bedetached from the holding member, and the holding member can be removedfrom the tissue pocket.

BRIEF DESCRIPTION OF THE DRAWINGS

Reference will now be made to exemplary embodiments, examples of whichare illustrated in the accompanying drawings. Wherever possible, thesame reference numbers will be used throughout the drawings to refer tothe same or like parts. The drawings are not necessarily to scale.

FIG. 1 is a perspective view of a system comprising a sample ofbiocompatible material and a device for surgical breast procedures,according to certain embodiments.

FIGS. 2A, 2B, and 2C are front, back, and side views, respectively, of aholding member for use in a device for surgical breast procedures,according to certain embodiments.

FIG. 3 is a top view of a backing member for use in a device forsurgical breast procedures, according to certain embodiments.

FIG. 4 is a perspective view of a system comprising a sample ofbiocompatible material and a device for surgical breast procedures,according to certain embodiments.

FIGS. 5A and 5B are front and rear views, respectively, of a backingmember for use in a device for surgical breast procedures, according tocertain embodiments.

FIG. 6 is a perspective view of a system comprising a sample ofbiocompatible material and a device for surgical breast procedures,according to certain embodiments.

FIG. 7 is a perspective view of a backing member for use in a device forsurgical breast procedures, according to certain embodiments.

FIG. 8A is a rear view of a backing member for use in a device forsurgical breast procedures, according to certain embodiments.

FIG. 8B is a side view of a backing member for use in a device forsurgical breast procedures, according to certain embodiments.

FIG. 9A is a rear view of a device for use in surgical breastprocedures, according to certain embodiments.

FIG. 9B is a front view of a device for use in surgical breastprocedures, according to certain embodiments.

FIG. 10 illustrates use of a system for facilitating breast surgery,according to certain embodiments.

FIG. 11 is a perspective view of a system comprising a sample ofbiocompatible material and a device for surgical breast procedures,according to certain embodiments.

FIG. 12 is a perspective view of a device for surgical breastprocedures, according to certain embodiments.

DESCRIPTION OF EXEMPLARY EMBODIMENTS

Reference will now be made in detail to various embodiments of thedisclosed devices and methods, examples of which are illustrated in theaccompanying drawings. Wherever possible, the same reference numberswill be used throughout the drawings to refer to the same or like parts.

In this application, the use of the singular includes the plural unlessspecifically stated otherwise. In this application, the use of “or”means “and/or” unless stated otherwise. Furthermore, the use of the term“including”, as well as other forms, such as “includes” and “included”,is not limiting. Any range described herein will be understood toinclude the endpoints and all values between the endpoints.

The section headings used herein are for organizational purposes onlyand are not to be construed as limiting the subject matter described.All documents, or portions of documents, cited in this application,including but not limited to patents, patent applications, articles,books, and treatises, are hereby expressly incorporated by reference intheir entirety for any purpose.

The present disclosure relates generally to devices for surgical breastprocedures and systems and methods relating to such devices. The devicescan be used for tissue augmentation, repair or regeneration of damagedtissue, and/or correction of tissue defects. As such, the device,systems, and methods discussed herein can be suitable for a wide rangeof surgical applications, such as, for example, aesthetic surgery,breast reconstruction, breast augmentation, breast enhancement, breastreduction, and revisionary breast surgeries.

The devices discussed herein generally assist in surgical procedureswherein a sample of biocompatible material can be implanted within atissue pocket in a breast. A variety of synthetic or biologic materialscan be used. In various embodiments, the materials are capable of beingattached to or inserted into and/or fixed within the body for aprolonged period of time without undesirable local or systemic effects.As non-limiting examples, the materials can include medical-gradepolymeric materials; autologous, allogenic, or cadaveric tissue; and/orbiomatrices, such as acellular tissue matrices. As used herein,acellular tissue matrices refer to tissue-derived biomatrix structuresthat can be made from any of a wide range of collagen-containing tissuesby removing all, or substantially all, viable cells and all detectablesubcellular components and/or debris generated by killing cells.Suitable exemplary acellular tissue matrices include ALLODERM® andSTRATTICE™, which are acellular human and dermal tissue matrices,respectively, and are produced by LIFECELL CORPORATION (Branchburg,N.J.).

The sample of biocompatible material can support a tissue expander orbreast implant within a tissue pocket, such as a subcutaneous,subglandular, subfascial, or subpectoral tissue pocket. Correctplacement of the material can be important to the success of thesurgical procedure, and incorrect placement can result in undesirableaesthetic results and/or medial, lateral, or inferior displacement of atissue expander or breast implant, which may require additionalsurgeries to correct the location of the inframammary, lateral, ormedial folds. Correct placement of the material can be hindered bydifficulties in handling of the biocompatible material, difficultiesvisualizing the placement of the material, and difficulties manipulatingthe material within the tissue pocket, as well as movement whilefastening the material to the underlying tissue. By addressing any orall of these problems, the devices disclosed herein can make suchsurgical procedures more consistent, faster, and more reproducible.

FIG. 1 is a perspective view of a system 100 comprising a sample ofbiocompatible material 102 and a device 110 for surgical breastprocedures, according to certain embodiments. The system 100 cancomprise a holding member 101 and a backing member 103. The sample ofbiocompatible material 102 can be attached to the holding member 101,and the holding member 101 can be attached to the backing member 103.The holding member 101 and/or backing member 103 can provide stiffnessto the sample of biocompatible material, improving the ability of thesurgeon to visualize and manipulate the sample of biocompatible material102. The holding member 101 and the backing member 103 can togethermimic the dimensions of the sample of biocompatible material 102 and atissue expander or breast implant when placed in the tissue pocket. Whencorrectly positioned and oriented within an implant site, the sample ofbiocompatible material 102 can be fastened to the underlying tissue. Thedevice 110 can then be removed, leaving the sample of biocompatiblematerial 102 fastened to the underlying tissue.

As described further below, the device 110 and system 100 can be used toposition the sample of biocompatible material 102 at a desired locationwithin a tissue expander and/or breast implant site. For example, invarious embodiments, a holding member 101 can be shaped such that oneedge (distal edge 203, shown in FIGS. 2A), has a shape configured toproduce a desired contour of a portion of the breast. For example, thedistal edge 203 can be shaped to be positioned at or near a desiredlocation for the inframammary fold (IMF), a medial border of the breast,a lateral border of the breast, or a location comprising parts of theIMF, medial border of the breast, and/or lateral border of the breast.

FIGS. 2A, 2B, and 2C are front, back, and side perspective views,respectively, of a holding member 101 for use in a device 110 forsurgical breast procedures, according to certain embodiments. As shownin FIGS. 2A, 2B, and 2C, the holding member 101 can comprise a proximaledge 201 and a distal edge 203. A portion of the proximal edge 201 canbe convex, curving away from the distal edge 203. Similarly, a portionof the distal edge 203 can be convex, curving away from the proximaledge 201. The proximal edge 201 and the distal edge 203 of the holdingmember 101 can both be convex, thus making the holding member 101generally biconvex in shape. The holding member 101 can comprise a firstside 205 and a second side 207. It will be appreciated that the proximaledge 201 and distal edge 203 may have variations in their shapes and maynot be convex over their entire lengths. Furthermore, in someembodiments, at least one of the edges 201 and 203 can be substantiallystraight.

In some embodiments, the holding member 101 comprises at least oneindentation 209. The at least one indentation 209 can be positionedalong the distal edge 203 of the holding member 101 and can assist infastening of the sample of biocompatible material 102 to tissueunderlying the distal edge 203 of the holding member 101. The at leastone indentation 209 can be sized to permit passage of a suture, astaple, or an effective quantity of adhesive or similar surgicalfastener to fasten the biocompatible material 102 to the underlyingtissue. The at least one indentation 209 can be a curved or polygonalrecess or a slit in the distal edge 203. More than one indentation 209can be present, and the indentations 209 can be regularly or irregularlysized, shaped, and/or spaced and can be distributed along either theentire distal edge 203 or one or more portions of the distal edge 203.

At least one fastener 211 can be configured to attach to and/or hold asample of biocompatible material in apposition to the first side 205 ofthe holding member 101. In some embodiments, the fastener 211 can beattached to the holding member 101 proximate to the proximal edge 201,such that an edge of a sample of biocompatible material held inapposition to the first side 205 of the holding member 101 contacts theproximal edge 201 of the holding member 101. In some embodiments, the atleast one fastener 211 can comprise multiple regularly spaced clipsattached to the first side 205 of the holding member 101 and abuttingthe proximal edge 201 of the holding member 101. In some embodiments,the fastener 211 can be permanently attached to the first side 205 ofthe holding member 101. In other embodiments, the fastener 211 isremovably attached to the holding member 101. Such fasteners can be usedwith any of the variations of the holding members described herein tohold a biocompatible material in apposition to the devices describedherein.

At least one fastener 213 can be configured to attach to the backingmember 103 and/or the holding member 101. The at least one fastener 213can be configured to hold the backing member 103 in apposition to thesecond side 207 of the holding member 101. In some embodiments, the atleast one fastener 213 can comprise multiple clips interspersed atregular or irregular intervals between multiple indentations 209. Insome embodiments, the fasteners 213 can be permanently attached to theholding member 101 and/or backing member 103. In other embodiments, thefasteners 213 are removably attached to the holding member 101 and/orbacking member 103. Such fasteners can be used with any of thevariations of the holding members and backing members described.

Fasteners 211 and 213 can be chosen from a variety of differentfasteners, for example mechanical fasteners, such as clips, pins,clasps, buttons, buckles, cleats, zippers, VELCRO®, hook and eye,toggle, screw, nail, suture, wire, ties, permanent or temporary magnets;or chemical fasteners such as adhesives, pastes, gums, cements, binders,and/or bonding agents.

The holding member 101, backing member 103, fastener 211, and fastener213 can be associated with each other. As a non-limiting example, theholding member 101, backing member 103, fastener 211, and fastener 213can be provided for use as part of a kit or a collection. They can beprovided temporarily or permanently attached to one another andpartially or completely assembled into the device 110. In someembodiments, the holding member 101 and backing member 103 areconfigured to be attachable and detachable multiple times. In someembodiments, the holding member 101 and backing member 103 are formed asa unitary structure, i.e., are formed as a single material and/or arepermanently connected by an adhesive or other connection that does notpermit easy separation of the components from one another. Further, anyof the other devices and systems described herein can be provided as acollection or kit, as described in this paragraph.

Surgical breast procedures may require a variety of tissue expanderand/or breast implant sizes. A particular breast implant or expander mayrequire a certain tissue pocket size. Various disclosed embodimentsinclude backing members 300, 400, 500, and 600 that are capable ofmimicking tissue expanders or breast implants of various sizes and/orthe base width of a tissue site, increasing the flexibility and utilityof these embodiments. Furthermore, in certain embodiments, the backingmembers may be adjustable in size and/or shape, thereby allowingflexibility of use during a procedure.

FIG. 3 is a top view of the backing member 103 for use in a device 110for surgical breast procedures, according to certain embodiments. Thebacking member 103 includes a first dimension 303 and a second dimension305. In some embodiments, the first 303 and second dimensions 305 of thebacking member 300 can approximate first and second dimensions of atissue expander or breast implant. For example, the first and seconddimensions of a tissue expander or breast implant can comprise adiameter of the tissue expander or a distance measured along a portionof the circumference of the tissue expander or implant, and thedimension 303 and 305 can correspond to those dimensions of the tissueexpander or implant. As such, the backing member 103 can aid a surgeonin gauging the position of a biocompatible material 102 relative to thesize of a desired expander or implant within a tissue pocket, as well asassist in gauging the size of an implant site relative to a desiredexpander or implant.

The backing member 103 can include a variety of different shapes andsizes. In some embodiments, the backing member 103 includes a diskshape. The disk shape can include a detachable outer ring member 309,along which at least one indentation 311 can be positioned, as well asan inner disk member 313. In other embodiments, the disk is formed of aunitary structure, i.e., without a detachable ring. The at least oneindentation 311 can be sized to permit use of a suture, staple, or otherfixation device to secure a biocompatible material to tissue. In someembodiments, the disk 103 comprises at least one indentation 311positioned along the outer edge 312 of the detachable outer member(i.e., the detachable outer ring member 309) and extending into theinner disk member 313 (see inner extension 312). As such, a surgeon canmodify the size of the backing member 103 during a procedure by removingor replacing the outer ring member 309. For example, the outer ring canhave a diameter of about 12 cm, and the inner disk member 313 can have adiameter of about 11 cm. This embodiment permits a single backing member103 to mimic more than one tissue expander. In various embodiments, theindentations 311 can have a position corresponding to the location ofindentations 209 of the holding member 101.

FIG. 4 is a perspective view of a system 400 comprising a sample ofbiocompatible material 102 and a device 410 for surgical breastprocedures, according to certain embodiments. Similar to the system 100of FIG. 1, the system 400 can comprise a holding member 101 and abacking member 403. A sample of biocompatible material 102 can beattached to the holding member 101, and the holding member 101 can beattached to the backing member 403. The holding member 101 and/orbacking member 403 can provide stiffness to the sample of biocompatiblematerial, improving the ability of the surgeon to visualize andmanipulate the sample of biocompatible material 102. As noted above,however, the backing members discussed herein, can have a variety ofshapes and configurations, and the structure of backing member 403 isdescribed in more detail below.

FIGS. 5A and 5B are front and rear views, respectively, of the backingmember 403, according to certain embodiments. The backing member 403comprises a central support member 401 adjustably connected to aplurality of vanes 405. The vanes 405 can be flat, with a top surfaceand a bottom surface, or can have some degree of curvature. The vanes405 are distributed around the central support member 401, for examplein a circular arrangement. These vanes 405 can circumferentially overlapto form a circular shape comprising a diameter 407 and an outside edge409. In some embodiments, for example, each vane 405 in the circularformation has two adjacent vanes. In such embodiments, each vane 405 inthe circular formation can be either above the two adjacent vanes, belowthe two adjacent vanes, or above one adjacent vane and below the otheradjacent vane.

In some embodiments, the adjustable connection between the centralsupport member 401 and each vane 405 permits that vane 405 to move withrespect to the central support member 401, the movement having acircumferential component. For example, as shown in FIG. 5B, at leastone vane 406 can be moved circumferentially to reduce the area ofbacking member 403. The circumferential component of this movementcauses the outside circumference of the circular shape to increase ordecrease and can affect the degree of circumferential overlap betweenthe vanes 405. Each of the vanes 405 can have at least two ends,tapering from a broader end distal to the central support member to anarrower end proximal to the central support member.

As with the embodiment of FIG. 1, the device 410 can include one or morefasteners 213 that can be attached to the holding member 101 proximateto the distal edge 203 of the holding member 101 and/or to the backingmember 403 to hold the holding member 101 and backing member 403 inapposition. In such embodiments, when the backing member 403 is held inapposition to the second side 207 of the holding member 101, the outsideedge 409 can be held in contact with the distal edge 203 of the holdingmember 101.

The backing member 403 can further include one or more indentations 411.The indentations 411 can be positioned along at least one edge of thebacking member 403 at a position corresponding to the position ofindentations 209 on the holding member 101. The indentations can bespaced and oriented to align with indentations of a backing member.

FIG. 6 is a perspective view of a system 600 comprising a sample ofbiocompatible material 102 and a device 610 for surgical breastprocedures, according to certain embodiments. The system 600 is similarto the systems 100 and 400 described above, except that the backingmember 603 of the device 610 has a different structure.

FIG. 7 is a perspective view of the backing member 603 for use in adevice for surgical breast procedures, according to certain embodiments.The backing member 603 comprises a curved segment 601 having a maximumlength and a connecting segment 607. In some embodiments, portions ofthe curved segment 601 can be a circular arc having a first end 604connected to a first end 611 of the connecting segment 607 and having asecond end 605 connected to a second end 609 of the connecting segment607. The width, thickness, and cross-sectional area of the curvedsegment 601 can vary, and the material dimensions and mechanicalproperties can be selected to produce a desired rigidity.

In some embodiments, the curved segment 601 can include a firstinterlocking section 613, a second interlocking section 615, and anadjustable connector 617 for adjusting the length of the curved segmentby securing the first interlocking segment 613 to the secondinterlocking segment 615. In some embodiments, the first interlockingsection 613 and the second interlocking section 615 can overlap to avarying degree determinable by the adjustable connector 617 foradjusting the length of the curved segment. By way of non-limitingexample, the first interlocking section 613 can be hollow, and thesecond interlocking section 615 can fit at least partially within thefirst interlocking section 613. Similarly, the second interlockingsection 615 can have a top face, the first interlocking section 613 canhave a bottom face, and the first interlocking section 613 can contactthe second interlocking section 615 face-to-face.

The adjustable connector 617 for adjusting the length of the curvedsegment can prevent unintentional changes in the overlap between thefirst interlocking section 613 and the second interlocking section 615,thus preventing unintentional alteration of the length of the curvedsegment 601. As shown in FIG. 7, for example, the adjustable connector617 for adjusting the length of the curved segment can comprise a buttonprojecting from the second interlocking section 615 through a slot inthe first interlocking section 613. By projecting through the slot, thebutton restricts the relative movement of the first 613 and second 615interlocking sections. Alternatively, other mechanisms can be usedinstead of a button.

In some embodiments, at least one fastener 213 (as depicted with respectto the backing member and holding members described above) can beattached to the holding member 101 proximate to the distal edge 203 ofthe holding member 101. In such embodiments, when the backing member 603is held in apposition to the second side 207 of the holding member 101,a portion of the curved segment 601 can be held in contact with thedistal edge of the holding member 101. Similarly, the at least onefastener 213 can hold a portion of the connecting segment 607 in contactwith the distal edge of the holding member 101.

FIG. 8A is a rear view of a backing member 800 for use in a device forsurgical breast procedures, according to certain embodiments; and FIG.8B is a side view of the device of FIG. 8A. The backing member 800comprises a first overlapping member 801 having a first end 807 and asecond end 809 and a second overlapping member 803 having a first end804 and a second end 805. Each overlapping member can be thin,substantially flat, and substantially longer than it is wide. The firstoverlapping member 801 can overlap the first end 804 of the secondoverlapping member 803. An adjustable connector 808 can be provided tocontrol the relative position and orientation of the two overlappingmembers 801, 803 and to connect the first overlapping member 801 and thesecond overlapping member 803. As shown in FIG. 8B, the device caninclude fasteners 818 for attachment to a holding member.

The adjustable connector 808 can prevent translation of either the firstoverlapping member 801 or the second overlapping member 803perpendicular to a plane formed by the first overlapping member 801 andsecond overlapping member 803. The adjustable connector 808 can alsopermit limited translation of the first overlapping member 801 and thesecond overlapping member 803 with respect to each other and limitedrotation around the point of intersection of the first overlappingmember 801 and second overlapping member 803 in a plane formed by thefirst overlapping member 801 and second overlapping member 803. Each ofthe first overlapping member 801 and second overlapping member 803 canhave a slot, indentation, or similar cut-out. Such slot, indentation, orsimilar cut-out can overlap, and the adjustable connector 808 caninclude a pin, dowel, threaded or unthreaded rod, screw, or similarconnector inserted through the cut-outs in the first overlapping member801 and second overlapping member 803. Such a connector can be securedat one or both ends with a cotter pin, nut, bolt, or similar lockingmechanism such that the first overlapping member 801 and secondoverlapping member 803 are held in contact with variable force. Thedegree of force can be decreased to permit an intentional change in therespective position and orientation of the first overlapping member 801and second overlapping member 803 and then increased to preventunintentional changes in the respective position and orientation of thefirst overlapping member 801 and second overlapping member 803. In thismanner, the position and the orientation of the first overlapping member801 and second overlapping member 803 can be adjusted, enabling thebacking member 800 to mimic the dimensions of the tissue expander.

In some embodiments, the first overlapping member 801 can furthercomprise a first interlocking member 811 and/or a second interlockingmember 813. The interlocking members 811, 813 can allow adjustment ofthe length of the overlapping member 801. Each of the first interlockingmember 811 and second interlocking member 813 can have a slot,indentation, or similar cut-out. Such cut-outs can overlap and a pin,dowel, threaded or unthreaded rod, screw, or similar connector can beinserted through said cut-outs. Such connector can be secured at one orboth ends with a cotter pin, nut, bolt, or similar locking mechanismsuch that the first interlocking member 811 and second interlockingmember 813 are held in contact with variable force. The length of thefirst overlapping member can be adjusted so that the backing member willmimic tissue expanders or implants of various sizes.

FIG. 9A is a rear view of a device 900 for use in surgical breastprocedures, according to certain embodiments. The device 900 comprises aholding member 101 and a backing member 800′. Backing member 800′ canhave a variety of configurations. In one embodiment, backing member 800′has a T-shape and can incorporate features, as described with respect toFIG. 8, but the backing member 800′ can have a variety of differentshapes.

In certain embodiments, the backing member 800′ can be integrally formedas a part of or permanently connected to the holding member. Forexample, as shown in FIG. 9A, the backing member 800′ can be permanentlyattached to the holding member 101 to provide desired rigidity to theholding member. The backing member 800 can be attached to the holdingmember using an adhesive and/or by embedding the backing member 800within the holding member 101, e.g., by embedding within a polymericmaterial forming the backing member.

FIG. 9B is a front view of the device 900′ for use in surgical breastprocedures, according to certain embodiments, before final assembly. Asshown, the backing member 800′ can be formed of the same material as theholding member 101′, or can be formed of another material attached toand extending from the holding member 101′. The backing member 800′ canthen be bent or folded and connected to the surface of the holdingmember. As with each of the devices described herein, the devices 900and 900′ can include fasteners 211 for removably attaching a biologicmaterial to the device for implantation of the biologic material.

FIG. 10 illustrates use of a system for facilitating breast surgery,according to certain embodiments. In particular, FIG. 10 illustrates useof the system 900′ of FIG. 9B. Any system described herein, however, maybe similarly used as part of a method for facilitating breast surgery.The method for facilitating breast surgery may first include creating atissue pocket in a breast. In one embodiment, for example, an incisioncan be made in the inframammary fold or other desired location near thebreast 1000; the pectorialis muscle can then be released and raised; anda tissue pocket 1010 created partially or completely under thepectorialis muscle. Alternatively, the tissue pocket 1010 can be formedfor placement of an implant anterior to the pectoralis muscle in asubcutaneous or subglandular pocket.

The method for facilitating breast surgery may further include selectinga system for facilitating the placement of biocompatible material 102including a holding member and/or a backing member. As described herein,the holding member and the backing member may be fastened to oneanother. The holding member and the backing member may be selected sothat when the holding member and the backing member are placed in thetissue pocket, they mimic the dimensions of a biological sample 102and/or a tissue expander or implant. In addition, or alternatively, theholding member may be selected so that its distal edge 203 has a shapeconfigured to produce a desired contour of a portion of the breast. Inone embodiment, for example, a device operator may select a holdingmember and a backing member that each include a desired size and shape.Alternatively, or in addition, a device operator may adjust the size andshape of the holding member and/or backing member so that a desired sizeand shape may be achieved.

Prior to insertion of the holding member and backing member into thetissue pocket 1010, the method for facilitating breast surgery mayinclude attaching a sample of biocompatible material 102 to the holdingmember. Attachment may include any suitable means described herein orknown to those skilled in the art so long as the sample of biocompatiblematerial 102 can be detached from the holding member upon placement inthe created tissue pocket 1010.

The sample of biocompatible material 102 may be attached at any suitablelocation on the holding member, such that the sample of biocompatiblematerial 102 can be placed in a desired position within the tissuepocket 1010. In one embodiment, as illustrated in FIGS. 1 and 2A-C, forexample, the method may include attaching the sample of biocompatiblematerial 102 with at least one fastener 211 proximate to the proximaledge 201 of the holding member 101, such that the sample ofbiocompatible material 102 is held in opposition to the first side 205of holding member 101. The at least one fastener 211 may be any suitablefastener described herein or known to those skilled in the art,including, but not limited to a clip, suture, wire, tie, adhesive,paste, or gum.

Once the sample of biocompatible material 102 is attached to the holdingmember, the method for facilitating breast surgery can further includeinserting the holding member, backing member and sample of biocompatiblematerial 102 at any suitable location within the created tissue pocket1010. For example, suitable locations within the created tissue pocketmay include, but are not limited to a location at or near a desiredlocation for the inframammary fold, medial border of the breast, and/orlateral border of the breast.

Upon placement of the holding member, backing member, and sample ofbiocompatible material 102 in a desired location within the createdpocket, the sample of biocompatible material 102 may be fastened tounderlying tissue in the breast. Fastening may be accomplished via anyfastening means known to those skilled in the art including, but notlimited to, a suture, a staple, and/or an effective quantity ofadhesive. Fastening of the sample of biocompatible material 102 to theunderlying tissue in the breast may occur while the sample ofbiocompatible material 102 is attached to the holding member. In oneembodiment, for example, the fasteners may pass through at least oneindentation 209 in the distal edge 203 of the holding member 101.

Once the sample of biocompatible material 102 is fastened to theunderlying tissue in the breast at the desired location, the sample ofbiocompatible material 102 may be detached from the holding member, andthe holding member and the backing member may be removed from thecreated tissue pocket 1010.

FIG. 11 is a perspective view of a system comprising a sample ofbiocompatible material 102 and a device 120 for surgical breastprocedures, according to certain embodiments. As shown, the device 120is a unitary structure. That is to say, the device includes a holdingmember 121, which has a shape similar to those described above (seeelement 101). In the embodiment of FIG. 11, however, the device does notinclude a separate backing member. Rather, the device 120 is formed of amaterial having desired flexibility/rigidity such that a separatebacking member is not needed. The device 120 has indentations 209, whichfunction like those described with reference to holding member 101.

In each of the embodiments described above, the backing member and/orholding member are depicted as substantially flat objects. The devicescan, however, have a number of suitable three-dimensional shapes. Forexample, FIG. 12 is a perspective view of a device for surgical breastprocedures, according to certain embodiments. As shown, the devicecomprises a backing member 130 having a curved or cup-likeconfiguration. The configuration may be selected to mimic an implantsite and/or a tissue expander or implant. Further, a holding member maybe configured to have a similar shape. In addition, the backing membermay be formed of a flexible material, and the holding member can beprovided in a range of suitable shapes to produce a desired shape forthe backing member 130 at the time of use.

In addition, the holding members described herein, as well as thebiocompatible materials for use therewith, can have any desired shape.For example, the holding member (with or without a backing member ofsimilar or different shape) and/or biocompatible material can berectangular, square, ovoid, triangular, trapezoidal, or any other shape.Such holding members can include a plurality of indentations along atleast one edge to assist in fastening the biocompatible material totissue.

Other embodiments will be apparent to those skilled in the art fromconsideration of the specification and practice of this disclosure. Itis intended that the specification and examples be considered asexemplary only, with the true scope and spirit of the disclosed devicesand methods being indicated by the following claims.

1. A method for preparing a site within a breast comprising: creating atissue pocket within or posterior to a breast; positioning within thetissue pocket a template comprising a sample of biocompatible materialcomprising a proximal edge and a distal edge, a holding membercomprising a proximal edge and a distal edge, and a backing member,wherein the proximal edge of the biocompatible material is detachablyconnected proximate to the proximal edge of the holding member and thebacking member is detachably connected proximate to the distal edge ofthe holding member; fastening the distal edge of the biocompatiblematerial to tissue within or surrounding the tissue pocket; and removingthe holding member and the backing member from the tissue pocket.
 2. Themethod of claim 2, wherein the biocompatible material is fastened totissue at or proximate to an inframammary fold.